Risk Analysis for Online Non-Viable Particle Count Sampling Location

The particle counter is used to monitor particles in clean room and initiate an alarm when the process goes out of specification and generates unacceptable numbers of particles.The system is used as early identification of possible contamination in critical aseptic area.The critical aseptic area is where critical aseptic process shall be carried out.The particle counting system consist of number of particle counters installed on different location of Grade A and Grade B and monitored centrally using  a SCADA based software.The risk analysis includes determination of the appropriate number of NVPC sampling points and their locations.